510(k) · Cleared
ClearedSpec Model M-31
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Source Production & Equipment Co., Inc. · KXK Source, Brachytherapy, Radionuclide
Cleared on Apr 22, 2009 as substantially equivalent to K994317 (Implant Sciences Corp., 2000) and 1 other predicate after a 68-day review. Its family tree reaches back 4 generations to 1991. 1 later device descends from it.
- Decided
- Apr 22, 2009
- Review
- 68 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K914281 (1991). 14 ancestors in all, the oldest K852542 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK914281 I-125 Seeds, Code: 6711Medi-Physics Inc. Dba Nycomed Amersham Imaging · 1991
- 3 generations backK982421 Imagyn 125 I Seed, Model IS 125International Isotopes, Inc. · 1998
- 2 generations backK990193 Iodine Brachytherapy Seeds, Model 3000Implant Sciences Corp. · 1999
- 1 generation backK994317 I-Plant, Model 3500Implant Sciences Corp. · 2000
- This deviceK090366 Spec Model M-31Source Production & Equipment Co., Inc. · 2009
- Descendant · cites it directly · 0 of its ownK141038 Ant Model 1Advanced Nuclide Technologies, LLC · 2014
Most influential descendants
Showing 1 of 1 · See all- K141038Ant Model 1Advanced Nuclide Technologies, LLC · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914281 | I-125 Seeds, Code: 6711 | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1991 | — |
| −3 | K982421 | Imagyn 125 I Seed, Model IS 125 | International Isotopes, Inc. | 1998 | — |
| −2 | K990193 | Iodine Brachytherapy Seeds, Model 3000 | Implant Sciences Corp. | 1999 | — |
| −1 | K994317 | I-Plant, Model 3500 | Implant Sciences Corp. | 2000 | — |
| 0 (this device) | K090366 | Spec Model M-31 | Source Production & Equipment Co., Inc. | 2009 | — |
| +1 | K141038 | Ant Model 1 | Advanced Nuclide Technologies, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KXK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KXK device
- #1 K242818 IsoSpherescore 10.9 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K994317 | I-Plant, Model 3500Summary page 1…Implant Sciences I-Plant Model 3500 (.. Iodine Brachytherapy Seed), cleared under 510(k) number K994317 dated 21 March 2000, and Implant Scien… | 2000 |
| * | K042864 | Implant Sciences Corp, Model HDR-4140Summary page 1…Implant Sciences Corp. HDR 4140 16 9Ytterbium High Dose Rate Brachytherapy Source, cleared under 510(k) number K042864 dated 06 January 2005 (4) Description of SPEC Model M-31 '69Ytterbium Brachyth… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141038 | Ant Model 1 | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 6.7 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K141038 (Advanced Nuclide Technologies, LLC, 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K994317.
How does its category compare?
All KXK devicesKXK Source, Brachytherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · KXK
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KXK
158in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KXK
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KXK
7in 2025
MAUDE reports naming product code KXK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 42 | 0 | 9 |
| 2008 | 1 | — | 1 | 15 |
| 2009 | 7 | 63 | 0 | 10 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 5 | 94 | 1 | 35 |
| 2012 | 3 | 109 | 1 | 4 |
| 2013 | 3 | 127 | 0 | 29 |
| 2014 | 8 | 96 | 0 | 13 |
| 2015 | 2 | — | 0 | 6 |
| 2016 | 4 | 49 | 1 | 40 |
| 2017 | 2 | — | 0 | 41 |
| 2018 | 1 | — | 0 | 28 |
| 2019 | 2 | — | 0 | 10 |
| 2020 | 3 | 158 | 0 | 15 |
| 2021 | 0 | — | 0 | 62 |
| 2022 | 1 | — | 0 | 26 |
| 2023 | 1 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 2 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Source Production & Equipment Co., Inc. (SPEC) Model M-31 169Ytterbium Brachytherapy Sources, with individual activities up to 5 mCi (185 MBq), are indicated for temporary or permanent interstitial, intracavitary, intraluminal or intraoperative implantation or surface application to treat selected localized tumors. They can be used either as primary treatment for unresectable tumors, or as treatment for residual disease after excision of primary or…
Read the full statement (108 words)
Source Production & Equipment Co., Inc. (SPEC) Model M-31 169Ytterbium Brachytherapy Sources, with individual activities up to 5 mCi (185 MBq), are indicated for temporary or permanent interstitial, intracavitary, intraluminal or intraoperative implantation or surface application to treat selected localized tumors. They can be used either as primary treatment for unresectable tumors, or as treatment for residual disease after excision of primary or recurrent tumors such as for lung cancer. Model M-31 Brachytherapy Source may be used concurrently with or following treatment with other interventions, such as external beam therapy, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate, breast and other accessible tumors are commonly treated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090366 · printed Nov 3, 2026
Cite this page
510(k) Report. “K090366: Spec Model M-31.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K090366
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026